4D Molecular Therapeutics Inc FDMT announced interim clinical data from cohort 1 of the Phase 1/2 trial of intravitreal 4D-150 for Wet Age-Related Macular Degeneration (wet AMD).
4D-150 was safe and well tolerated, with no serious adverse events or dose-limiting toxicities reported.
No clinically significant intraocular inflammation, endophthalmitis, retinal vasculitis, retinal artery occlusion, choroidal effusions, and hypotony were reported to date.
Also see: 4D Molecular Shares Fall After Filing For Fabry Disease Trial Amendment.
Cohort 1 patients (n=5) received a single intravitreal injection of 4D-150 (3E10 vg/eye); these patients were high-need patients who, in the 12 months preceding trial enrollment, had a mean annualized anti-VEGF injection rate of ~11.
Following intravitreal 4D-150, the annualized anti-VEGF injection rate was reduced by 96.7%.
80% of patients have remained anti-VEGF injection-free, with a follow-up of ~40, 36, 32, or 16 weeks.
The company expects to initiate enrollment in the randomized Phase 2 stage of the trial in Q1 2023.
Additional clinical data from all three Dose Exploration cohorts on this trial is expected in Q2 2023.
Price Action: FDMT shares are up 8.11% at $13.52 on the last check Monday.
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